“The FDA is really setting a new norm” by approving cholesterol drugs that have no evidence of actually preventing heart attack, Patterson said.

Now that statins have lost government patent protection, generic statins can be had for $250 per year while these new class of injectable cholesterol drugs (PCSK-9 inhibitors) may cost over $14,000 per year, although some industry estimates come in lower. To quote from the article, “The costs of the new cholesterol fighters is compounded by the fact that patients would be expected to take them for the rest of their lives.”

This class of drugs “have the potential to grow over the next several years to become the costliest therapy class our country has seen,” said Steve Miller, senior vice president and chief medical officer at Express Scripts, a leading pharmacy benefit manager, in a statement.

The side effects include “sore throats, upper respiratory tract infections, flu, back pain and bruises or sore where the injections are given, according to the FDA,” but then again, this was just what was observed in small clinical trials. Even mainstream doctors are questioning these drugs and the various unknown side effects from longer-term use. Other reports I have read point to the potential for neuro-cognitive adverse events.

In spite of the fact that allowable cholesterol levels are politically influenced to get more people on profitable drugs, and in spite of the fact that there is no evidence that these injectable drugs can prevent heart attacks because the complete data is not yet all in, Time magazine has referred to these drugs “game-changers.” I do think the PCSK9 inhibitors can potentially be a great alternative to statins for people who really have a concrete need for it, but the problem is that conventional wisdom and the medical-pharmaceutical-industrial complex have blurred the lines between real need and merely pushing drugs for profit onto as much of the population as possible. Bill Sardi recently wrote an article on this that I think is extremely informative for understanding the plus-side of PCSK9 inhibitors as opposed to the horrors of statins.

Pharmacy benefit managers and integrated providers already are mulling their options, recognizing it will difficult to limit use. Dr. Troyen Brennan, chief medical officer at CVS Health, and his colleagues, writing in Health Affairs, said pharmacy benefit managers will try to limit the number of patients taking the new drugs, based on clinical guidelines and expert opinion. Patients “will likely require laboratory tests to show evidence of muscle inflammation or liver damage before allowing treatment for those with statin intolerance,” they said in the article. “But it is unclear how much these medical management efforts will limit utilization.”

Indeed, the pressure is already on for pharmacy benefit managers and health insurers to provide coverage to patients in need, and how that need will be determined will surely be influenced by political dictates and entitlement theory.

2 Responses to The War on Cholesterol is Too Profitable to Give Up

Onlooker says:

August 28th, 2015 at 1:33 pm

Of course the whole thing is based on the specious premise that “high” cholesterol levels are a problem at all, much less a cause of heart disease.

You may be familiar with the work of Dr. Malcolm Kendrick, but if not here’s his excellent blog: http://drmalcolmkendrick.org/ He covers this topic extensively and wrote a great book too: The Great Cholesterol Con. Of course many others have exposed the lies in this area too, but he’s got a great wit and thus is informative and entertaining.